| Outcome Measures: |
Primary: The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c)., 26 weeks | Secondary: Body weight (Kg), 26 weeks|Hip and Waist circumference (Cm), 26 weeks|Incretin hormones (Blood sampling), GLP-1, GLP-2 and GIP, 26 weeks|Bone Markers (Blood sampling), Calcitonin, Vit-D, Ca, Phosphate, Mg, PTH, PINP, CTX, OC, 26 weeks|Lipid Profile (Blood sampling), LDL, HDL, triglycerider, total kolesterol,, 26 weeks|Hormones (blood sampling), Insulin, glucagon and C-peptide, 26 weeks|Visceral fat, DXA scanning, 26 weeks|Android to Gynoid fat ratio, DXA scanning, 26 weeks|Total body fat, DXA scanning, 26 weeks|Bone density, DXA scanning, 26 weeks|Psychopathology, PANSS-6 interview, 26 weeks|Registration of body movements/level of activity with a sensor, Activity measurements (approximate for sleep, inactivity, energy expenditure and steps taken by the patient) will be collected continuously by the use of a wearable activity device worn by the patient for 1 week from inclusion day and 1 week at the end of the study, 26 weeks|Reward value of sweet and fatty candy, Clicker test, 26 weeks|Alcohol use, Questionnaires: AUDIT, 26 weeks|Tobacco use, Questionnaires: FNTD, 26 weeks|Drug use, Questionnaires: DUDIT, 26 weeks|Schizophrenia quality of life scale, Questionnaire: SQLS, 26 weeks|Psychosocial disability, Rating GAPD, 26 weeks|Liver function (blood sampling), ALT, ALP, AST, trombocytes and bilirubin, 26 weeks|Proteomic analyses (Blood sampling), Inflammatory biomarkers and cytokines: IFN-γ, TNF-α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, MDA, plasma antioxidants uric acid and, vitaminC, 26 weeks|Proteomic analyses (Urine sampling), biomarkers for measurement of systemic oxidative stress on DNA and RNA: 8-oxo-7,8-dihydro2´-deoxyguanosine (8-oxodG) and 8-oxo-7,8-dihydroguanosine (8-oxoGuo, 26 weeks|FIB-4 score, A non-invasive scoring system for Liver Fibrosis is a non-invasive scoring system based on several laboratory tests (ALT, AST, trombocytes) and age, 26 weeks|Vitals, Blood pressure and pulse, 26 weeks|Insulin sensitivity and beta cell function, evaluated by homeostatic model assessment, 26 weeks
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| Locations: |
Psychosis Research Unit, Aarhus University Hospital, Psychiatry,, Aarhus, 8200, Denmark|Psychiatric Centre Copenhagen, Rigshospitalet, Copenhagen, 2100, Denmark|Psychiatric Centre Nordsjaelland, Hillerød, Hillerød, 3400, Denmark
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